Post-thoracotomy PainPhase 3NCT00934193
Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
A Phase 3 study testing Gabapentin in people with Post-thoracotomy Pain, run by University of Kansas Medical Center.
Trial summary
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-thoracotomy Pain
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Undergoing non-cardiac thoracic surgeries
- Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.
Who cannot join
- Current gabapentin use or current treatment for neuropathic pain.
- Pregnant or considering becoming pregnant.
About this study
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
Read the detailed description
This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
- Conditions
- Post-thoracotomy Pain
- Being tested
- Gabapentin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
PlaceboDrug
Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Not described Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-thoracotomy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wichita Medical Research and Education Foundation, Ascension Via Christi Hospitals
- Responsible party
- Sponsor
- Investigators
- Sinisa Malinovic, MD, Principal investigator, Ascension Via Christi Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934193
- Sponsor's protocol ID
- 220081131
- Other IDs
- WMREF 80104-257
- Status last verified
- Dec 2015
- First submitted
- 6 Jul 2009
- Last updated
- 16 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
- ClinicalTrials.gov ID
- NCT00934193
- Acronym / sponsor ID
- 220081131
- Conditions
- Post-thoracotomy Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Wichita Medical Research and Education Foundation, Ascension Via Christi Hospitals
- Study start
- Jul 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
Detailed description
This study is a prospective double blind randomized controlled trial evaluating the peri-operative use of gabapentin in the prevention or modulation of post-thoracotomy hyperalgesia. Treatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: Gabapentin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Undergoing non-cardiac thoracic surgeries
- Patients determined to have impaired decisional capacity with respect to the provision of informed consent or prisoners will not be included in the study.
Key exclusion criteria (2 listed)
- Current gabapentin use or current treatment for neuropathic pain.
- Pregnant or considering becoming pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinTreatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit. | Drug | Gabapentin |
| PlaceboTreatment will consist of a 600 mg dose of gabapentin or placebo given preoperatively the night before surgery, based on a computer generated randomized assignment. The treatment group will continue to be medicated with gabapentin 300 mg twice daily for one month following surgery. Those not included in the treatment arm of the study will continue to take a placebo for the same duration. Follow-up will consist of a postoperative visit at approximately 48 hours and a one month clinical visit. | Drug | Placebo |
Primary outcome
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain.
Time frame: 6 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
Related trials for Post-thoracotomy Pain
RecruitingPhase 2/3
Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
Nerve Block/Methods
Not yet recruiting
Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control
Postoperative Pain
Recruiting
Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain
Analgesia
Recruiting
SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery
Chronic Post-thoracotomy Pain, Neuropathic Pain
Not yet recruiting
Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia
Post Thoracotomy Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sinisa Malinovic, MD principal investigator
Ascension Via Christi Hospitals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Post-thoracotomy Pain, run by University of Kansas Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to determine if gabapentin can decrease or prevent chronic post-thoracotomy pain. (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.